NCT00463242

A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)

An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 501 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Agomelatine	Either 25 mg or 50 mg agomelatine orally once daily
DRUG	paroxetine
DRUG	placebo

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-06-01
• First posted: 2007-04-20
• Last updated: 2020-12-23

Locations

47 sites across 2 countries: United States, Puerto Rico